Exercise therapy and low back pain - Insights and proposals to improve the design, conduct, and reporting of clinical trials

Study Design. A report on plenary presentations and discussions of an expert panel and workshop ("Exercise as a treatment for subacute low back pain") that was held at the Amsterdam Forum VIII on Low Back Pain Research in Primary Care. Objective. To highlight important issues regarding the design, conduct, and reporting of exercise trials and to provide suggestions for improvement in each domain. Summary of Background Data. Despite improvements in the methodologic quality of randomized clinical trials on low back pain (LBP), current trials on exercise therapy still show methodologic flaws in the design and reporting of studies. Methods. Important issues in the design, conduct, and reporting of exercise trials for LBP were introduced by 4 presenters, and this was followed by a group discussion among 40 attendees. Conclusions and recommendations were extracted by the workshop panelists and summarized in this paper. Results. Workshop discussion led to the following recommendations: (1) specify a theoretical framework for exercise therapy for designing the intervention and selecting appropriate treatment efficacy measures; (2) to overcome blinding problems in exercise trials, include sham interventions and assess the success of blinding; (3) evaluate the role of patient-provider interactions through the use of self-report or observational measures; (4) to assure quality of treatment, use exercise interventions that reference existing exercise guidelines; (5) use subgroup analyses to identify subgroups of patients most likely to benefit; (6) in reporting exercise trials, include an extensive description of the study population, a detailed exercise protocol, and some measure of patient compliance; (7) further categorization of exercise interventions is needed, in terms of concept, mode, intensity, duration, frequency, and length; and (8) trial registration and publication of detailed study protocols may help to strengthen the evidence-based concerning exercise therapy for LBP. Conclusion. By paying proper attention to issues concerning the design and reporting of exercise protocols when conducting future exercise trials, research may provide a stronger evidence basis for recommending or not recommending various exercise therapies for LBP.